Melissa Spang

Experience

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  Ben Venue Laboratories

  Jan 2004 - Dec 2013

  As a Quality Compliance Analyst, I was responsible for ensuring quality and compliance to cGMPs and international regulatory requirements through performance of internal and external audits and collaboration with cross-functional teams to drive tactical solutions to assigned areas of focus. I assisted in establishment of Compliance strategy and facilitated resolution and prevention of compliance risks. I supported inspection management, development, and execution of regulatory training. I assisted with supporting domestic and global compliance intelligence and interpretation of cGMP and Quality Systems involving regulatory agencies including but not limited to FDA, MHRA,EMEA, PMDA, ANVISA, TGA, KFDA, etc. I assisted in identifying and communicating risks related to regulatory requirements and providing input to the organization for effectively interpreting and deploying new and changing regulatory requirements. Show less As a Quality Control Chemist I was responsible for preparing, executing, documenting, and verifying analystical testing. The testing included, but was not limited to, HPLC, GC, FTIR, UV, pH, titrations, and various other types of wet chemistry. I was also responsible at various times for creation, review, and approval of test methods and specifications. I was responsible for creation, review and approval of Quality Control related change controls. I performed work in in-process manufacturing testing, finished product testing, and stability testing. Show less

  • Quality Compliance Analyst

    Aug 2010 - Dec 2013

  • Quality Control Chemist

    Jan 2004 - Jul 2010
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  JALEX Medical

  Jan 2014 - Jun 2017

  Quality Systems/Regulatory Specialist

  Medical Device Design, Product Development & Regulatory Consulting: Accelerating Concept to MarketMedical Device Design & Development - Concept Generation and 2D/3D CAD- Medical Device Design per FDA regulations- Finite Element Analysis- Find manufacturing resources to create prototypes and production partsQuality - Quality Management System Development and Implementation per 21 CFR 820- ISO 13485, FDA, MDD, and Canadian Directive General and Facility Specific Training Programs- Company Representative during external audits by Regulatory and Third Party Auditors- FDA remediation assistance for 483 observations and warning lettersRegulatory- Regulatory Path Assistance & Product Classifications (Class I, II, III)- 510(k) submissions- Predicate Device Research - Device/Instrument Registration & Listing Show less

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  STERIS

  Jul 2017 - now

  • Quality Systems Manager

    May 2022 - now

  • Quality Engineering Supervisor

    Nov 2021 - May 2022

  • Senior Quality Engineer

    Jul 2017 - Nov 2021